A Study of Daily Rifapentine Combined With Isoniazid (1HP) for Tuberculosis Prevention in Children Less Than 13 Years of Age With and Without HIV

StatusRecruiting
PhasePhase 1/2
Started

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Record History

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  1. Recruitment opened Show 5 more changesShow less
    • Primary endpoints: details revised at 4 of 14 entries
    • Start date changed from estimate of Oct 15, 2026 to Sep 28, 2026
    • Eligibility criteria expanded, about 49 words
    • Secondary endpoints: details revised at 4 of 12 entries
    • Study sites revised (11)
  2. Start date: Jul 15, 2026 to Oct 15, 2026v4
  3. Start date: May 15, 2026 to Jul 15, 2026v3
  4. Start date: Dec 15, 2025 to May 15, 2026v2
  5. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
This study aims to find the proposed dose of Rifapentine (RPT) taken once daily with Isoniazid (INH) for 28 days to prevent tuberculosis (TB). The study will take place at multiple locations and children under 13 years old will be divided into two groups: one group will include children without HIV, and the other group will include children with HIV who are on antiretroviral treatment. Up to 144 children will participate, and participants in each group will be followed for 24 weeks.
Trial Details
NCT Number NCT07124559
Lead Sponsor National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institute of Mental Health (NIMH)
Conditions
(from sponsor)		 Tuberculosis
Related terms Latent Tuberculosis, Tuberculosis
Enrollment 144 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov